Skip to main content
. 2020 Jan 22;2020(1):CD012949. doi: 10.1002/14651858.CD012949.pub2

NCT01837355.

Trial name or title Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM‐1).
Methods Trial design: RCT.
Trial grouping: cross‐over, with 1‐week washout period.
Randomisation method: not specified.
Participants Inclusion criteria
  • Moderate to severe CF disease.

  • Aged 6 years to 20 years.


Exclusion criteria
  • Acute gastroenteritis 2 weeks prior to inclusion.

  • Chronic disease other than CF (except CF‐associated disorders).

  • Oral or parenteral antibiotics 2 weeks prior to inclusion.

  • Systemic steroids 4 weeks prior to inclusion.

  • Any probiotic intake.

Interventions Probiotic
  • Preparation: L rhamnosus (dose and preparation not specified).

  • Frequency of administration: daily.

  • Duration: 12 weeks.


Placebo
  • Preparation: placebo (dose and preparation not specified).

  • Frequency of administration: daily.

  • Duration: 12 weeks.

Outcomes Primary outcome measures
  • Faecal calprotectin

  • Pulmonary calprotectin


Time points for measurements: baseline, 12 weeks, 24 weeks.
Length of follow‐up: 25 weeks.
Starting date March 2013.
Contact information Dr Christian Kahlert, MD
Childrens's Hospital of Eastern Switzerland
St. Gallen, SG, Switzerland, 9008
Phone: +41714941111
Email address: christian.kahlert@kssg.ch
Notes